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What is STIOLTO RESPIMAT?

STIOLTO RESPIMAT is a fixed-dose combination of tiotropium bromide (LAMA) and olodaterol (LABA), delivered via the Respimat inhaler.1

STIOLTO RESPIMAT is indicated for the long-term, once-daily maintenance treatment of patients with COPD, including chronic bronchitis and/or emphysema.1

STIOLTO is NOT indicated to treat acute deterioration of COPD and is not indicated to treat asthma.

How STIOLTO RESPIMAT works: dual mechanisms of action

STIOLTO RESPIMAT contains two medications—tiotropium and olodaterol—that target two distinct physiological pathways.1

  • Tiotropium (LAMA component): Tiotropium is a long-acting, muscarinic antagonist, which is often referred to as an anticholinergic. In the airways, tiotropium inhibits the M3-receptors at the smooth muscle leading to bronchodilation. Its long duration of action (approximately 24 hours) supports once-daily dosing.1

  • Olodaterol (LABA component): Olodaterol is a long-acting beta2-adrenergic agonist. It works by activating beta2-adrenoceptors upon inhalation, triggering a cascade that leads to airway smooth muscle relaxation and bronchodilation. This pathway is independent of the anticholinergic mechanism of tiotropium.1

Why Dual Bronchodilation Matters:

The combination of LAMA and LABA mechanisms results in bronchodilation by targeting two distinct physiological pathways simultaneously.

The STIOLTO RESPIMAT soft mist delivery

STIOLTO RESPIMAT is the only LABA/LAMA for COPD delivered in soft mist1

Soft mist delivery helps patients with COPD inhale their medicine1

  • With the soft mist inhaler, just a slow, deep breath is required–no need to sharply inhale1*

  • Deep lung delivery means nebulized medicine reaches deep into the lungs2,3†

  • *
    As with all inhaled drugs, the actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between the actuation of the inhaler and inspiration through the delivery system. The duration of inspiration should be at least as long as the spray duration (1.5 seconds).
  • †
    It is important to note that a correlation between lung deposition and clinical efficacy has not been established.

Learn more about soft mist delivery with the STIOLTO RESPIMAT inhaler

STIOLTO in the context of COPD management

  • COPD is a progressive disease with persistent airflow limitation, chronic respiratory symptoms, and risk of acute exacerbations.

  • For patients with significant symptom burden or exacerbation risk, GOLD guidelines recommend dual bronchodilation with a LAMA/LABA combination before considering ICS addition when eosinophil counts are less than 300 cells/μL . STIOLTO is a single once-daily inhaler.4 - 1 DOSE = 2 Puffs Once Daily - Patients should not use more than 2 puffs every 24 hours.

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INDICATION for STIOLTO RESPIMAT

STIOLTO® RESPIMAT® (tiotropium bromide and olodaterol) Inhalation Spray is a combination of tiotropium, an anticholinergic, and olodaterol, a long-acting beta2-adrenergic agonist (LABA), indicated for the long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Important Limitations of Use

STIOLTO is NOT indicated to treat acute deterioration of COPD and is not indicated to treat asthma.

IMPORTANT SAFETY INFORMATION for STIOLTO RESPIMAT
CONTRAINDICATION

Use of a LABA, including STIOLTO RESPIMAT, without an inhaled corticosteroid (ICS) is contraindicated in patients with asthma.

STIOLTO is contraindicated in patients with hypersensitivity to tiotropium, ipratropium (atropine derivatives), olodaterol, or any component of this product.

In clinical trials and postmarketing experience with tiotropium, immediate hypersensitivity reactions, including angioedema (including swelling of the lips, tongue, or throat), itching, or rash have been reported. Hypersensitivity reactions were also reported in clinical trials with STIOLTO.

WARNINGS AND PRECAUTIONS

LABA as monotherapy (without an ICS), for asthma increases the risk of asthma-related death, and in pediatric and adolescent patients, increases the risk of asthma-related hospitalizations.

Do not initiate STIOLTO in patients with acutely deteriorating COPD, which may be a life-threatening condition, or used as rescue therapy for acute symptoms. Acute symptoms should be treated with an inhaled short-acting beta2-agonist.

STIOLTO should not be used more often or at higher doses than recommended, or with other LABAs as an overdose may result.

If immediate hypersensitivity reactions occur, such as urticaria, angioedema, rash, bronchospasm, anaphylaxis, or itching, discontinue STIOLTO at once and consider alternative treatment. Patients with a history of hypersensitivity reactions to atropine or its derivatives should be closely monitored for similar hypersensitivity reactions to STIOLTO.

If paradoxical bronchospasm occurs, discontinue STIOLTO immediately and institute alternative therapy.

STIOLTO can produce a clinically significant cardiovascular effect in some patients, as measured by increases in pulse rate, systolic or diastolic blood pressure, and/ or symptoms. If such effects occur, STIOLTO may need to be discontinued.

Use caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, in patients with known or suspected prolongation of the QT interval, and in patients who are unusually responsive to sympathomimetic amines.

Use with caution in patients with narrow-angle glaucoma. Instruct patients to contact a physician immediately if signs or symptoms of acute narrow-angle glaucoma develop.

Use with caution in patients with urinary retention especially in patients with prostatic hyperplasia or bladder-neck obstruction. Instruct patients to consult a physician immediately should any of these signs or symptoms develop.

Patients with moderate to severe renal impairment (creatinine clearance of <60 mL/min) should be monitored closely for anticholinergic side effects.

Be alert to hypokalemia and hyperglycemia.

ADVERSE REACTIONS

The most common adverse reactions with STIOLTO (>3% incidence and higher than an active control) were: nasopharyngitis, 12.4% (11.7%/12.6%), cough, 3.9% (4.4%/3.0%), and back pain, 3.6% (1.8%/3.4%).

DRUG INTERACTIONS

  • Use caution if administering adrenergic drugs because sympathetic effects of olodaterol may be potentiated.

  • Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate any hypokalemic effect of olodaterol.

  • Use with caution in patients taking non–potassium-sparing diuretics, as the ECG changes and/or hypokalemia may worsen with concomitant beta-agonists.

  • The action of adrenergic agents on the cardiovascular system may be potentiated by monoamine oxidase inhibitors or tricyclic antidepressants or other drugs known to prolong the QTc interval. Therefore, STIOLTO should be used with extreme caution in patients being treated with these drugs. Use beta-blockers with caution as they not only block the therapeutic effects of beta-agonists, but may produce severe bronchospasm in patients with COPD.

  • Avoid co-administration of STIOLTO with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects.

STIOLTO is for oral inhalation only.

The STIOLTO cartridge is only intended for use with the STIOLTO RESPIMAT inhaler.

Inform patients not to spray STIOLTO into the eyes as this may cause blurring of vision and pupil dilation.

CL-STO-100048 6.5.2019

Please see full Prescribing Information, Patient Information, and Instructions for Use for STIOLTO RESPIMAT.

References

  1. STIOLTO RESPIMAT [prescribing information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; January 2025.

  2. Wachtel H, Kattenbeck S, Dunne S, Disse B. The RESPIMAT® development story: patient-centered innovation. Pulm Ther. 2017;3(1):1-12.

  3. Anderson P. Use of RESPIMAT® Soft Mist™ Inhaler in COPD patients. Int J Chron Obstruct Pulmon Dis. 2006;1(3):251-259

  4. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Accessed, December 2, 2025. https://goldcopd.org/2026-gold-report-and-pocket-guide/